US20200054794A1 - Biodegradable Wire Implant - Google Patents

Biodegradable Wire Implant Download PDF

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Publication number
US20200054794A1
US20200054794A1 US16/540,910 US201916540910A US2020054794A1 US 20200054794 A1 US20200054794 A1 US 20200054794A1 US 201916540910 A US201916540910 A US 201916540910A US 2020054794 A1 US2020054794 A1 US 2020054794A1
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wire
proportion
implant
wire implant
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Jan Marten Seitz
Katrin Nagel
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Syntellix AG
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Syntellix AG
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Assigned to SYNTELLIX AG reassignment SYNTELLIX AG CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED ON REEL 050055 FRAME 0986. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: NAGEL, KATRIN, SEITZ, JAN MARTEN
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium
    • C22C23/06—Alloys based on magnesium with a rare earth metal as the next major constituent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
    • A61B17/848—Kirschner wires, i.e. thin, long nails
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/002—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working by rapid cooling or quenching; cooling agents used therefor
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/06—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of magnesium or alloys based thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A61L2300/604—Biodegradation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials

Definitions

  • the invention relates to a wire implant, in particular for wire osteosynthesis, and a corresponding method for its production.
  • wire implants are used to connect and fix the bone fragments.
  • K-wire spiked or Kirschner wires
  • Wire implants can also be used to wrap around bone fragments and in this way connect and fix them (wire cerclage).
  • Removal of the wires is usually done under general anaesthesia, which always entails a certain risk of anaesthesia.
  • K-wires made of stainless steel or titanium small openings and cavities in the bone always and inevitably remain, which must heal again.
  • WO 2015/137911 A1 describes an orthopaedic fastening device which may be designed as a K-wire and is coated with a degradable hydrogel. After implantation of the fastening device, the hydrogel increases in volume and thus contributes to the internal fixation of the fracture. The hydrogel is degraded over time.
  • the implant can be made of magnesium.
  • WO 2017/035072 A1 describes degradable, magnesium-based implants for bone fixation.
  • the magnesium alloy can also be used as a wire that is wound around bone for fixation (wire cerclage) or as a pin.
  • the aim of the invention is to provide a degradable wire implant which provides high strength with simultaneously high elasticity.
  • Biodegradable wire implants require some special mechanical properties of the resorbable metal, which may be less important for other implants such as screws, nails, plates or splints. In particular, high rigidity and high strength of the wire are necessary. Otherwise, the K-wire would warp, twist or kink when screwing into the bone.
  • a wire implant in particular for wire osteosynthesis, is proposed for positioning and/or fixing at least one broken or osteotomized bone, wherein the wire implant has undergone a heat treatment,
  • the wire implant consists of a biocompatible, biocorrodible magnesium alloy composed of metallic magnesium of at least 80 wt. %, a zinc proportion of 0.1 to 2.0 wt. %, a zirconium proportion of 0.1 to 2.0 wt. %, a proportion of rare earth metals of 0.1 to 10 wt. %, wherein the yttrium content among the rare earth metal content proportion is 0.1 to 5.0 wt. %, a manganese proportion of 0.01 to 0.2 wt. %, an aluminium proportion of less than 0.1 wt. %, a copper, nickel and iron proportion in each case of less than 0.1 wt. %, and a proportion of other physiologically undesirable impurities totaling less than 0.8 wt. %, wherein the remainder of the alloy is magnesium up to 100 wt. %.
  • wire implant includes all wires, such as spiked or Kirschner wires or wire cerclages that can be used for osteosynthesis.
  • the magnesium-based alloy contains at least 88 wt. % of magnesium, 0.10 to 1.00 wt. % of zirconium, 0.01 to 1.00 wt. % of zinc, 1.00 to 3.00 wt. % of yttrium and 2.00 to 5.00 wt. % of other rare earth metals. It is preferred that the magnesium-based alloy has an overall content of physiologically undesirable impurities of the metals iron, copper, nickel and aluminium of less than 0.02 wt. %, in relation to the alloy. In particular, the magnesium-based alloy contains less than 0.01 wt. % of aluminium, less than 0.20 wt. % of iron, less than 0.20 wt.
  • the magnesium-based alloy contains less than 0.01 wt. % of aluminium, less than 0.20 wt. % of zinc, less than 0.15 wt. % of manganese, less than 0.20 wt. % of lithium, less than 0.01 wt. % silicon, less than 0.01 wt. % of iron, less than 0.03 wt. % copper and less than 0.005 wt. % of nickel.
  • unavoidable other impurities means elements which, according to general medical experience, cannot be expected to have any adverse physiological effects and cannot be completely ruled out due to the lack of 100% purity of the starting materials. Examples are carbon, silicon, sodium, potassium, oxygen, nitrogen, hydrogen, calcium.
  • the wires must additionally undergo a heat treatment in order to achieve sufficient torsional strength for long, thin knitting needle-shaped implants.
  • the wire implant is subjected to heat treatment by solution annealing, quenching and subsequent artificial aging. Likewise, soft annealing is possible. This list is not exhaustive. Other methods of heat treatment are also possible for a person skilled in the art.
  • wires or wire sections treated by heat treatments are malleable and bendable.
  • heat treatment allows the degradation behaviour of the wire to be made different in individual sections. In this way it is possible to provide a wire implant which is customised to the patient or to the necessary treatment.
  • the basic mechanical properties of the wire implant are therefore determined by the composition of the magnesium alloy as well as the subsequent heat treatment, or by the interaction of these factors.
  • the values of the yield strength or tensile strength can be significantly lowered and the elongation at break increased.
  • the wires or wire sections treated by heat treatments are thus malleable and bendable.
  • particularly strong regions in terms of torsion and bending can also be produced by the heat treatment.
  • Aging achieves in particular high strengths, which in particular improve the tensile and torsional strength of the wire at the sites treated in this way.
  • Wires comprising segments of different strength or ductility have the advantage that, for example tribologically stressed parts of an implant, such as the tip intended for drilling, can be made particularly strong and thus hard, so the cutting work and the attrition/abrasion occurring during implantation are kept low. At the same time, the subsequent more ductile portion of the wire allows moulding to the area of operation and even allows the formation of a cerclage.
  • the segments of the wire resulting from the different heat treatments can have different degradation rates, by means of which, for example, the influences of areas of different tissues on the degradation behaviour of the magnesium alloy used can be compensated in a targeted manner.
  • the implant can be designed such that the portion of wire remaining in the soft tissue has a much lower rate of degradation than that in the bone. Since the degradation of magnesium in the soft tissue is faster because of the higher water content and the higher substance transport rate, heat treatment which results in a low degradation rate would be advantageous for the wire segment used here. In principle, in this way the degradation progress can also be controlled such that the wire dissolves in a targeted manner from its ends and not evenly over its entire surface. This can carry the advantage that the implant remains intact for a particularly long time at critical points.
  • the heat treatments can be used to make the degradation behaviour of the wire different in individual sections. Using heat treatment, degradation rates of 0.05 to 2.0 mm per year are possible in a heat-treated region.
  • the wire implant is heat-treated over its entire length.
  • the heat treatment takes place in at least one subsection.
  • heat treatment in about the middle third is advantageous, preferably in one third to two thirds of the total length of the wire implant.
  • the different possibilities of heat treatment such as aging and soft annealing can also be applied to a wire.
  • a wire having a high-strength tip can be produced, while the remainder of the wire is softer and more flexible.
  • the heat treatment can take place over the entire length of the wire implant or in at least one subsection.
  • the degradable wire implant is heat-treated over its entire length.
  • a heat treatment in about the middle third is advantageous.
  • the term subsection in the sense of this invention encompasses at least a region of 1% of the total length of the finished implant.
  • the elongation at break in a soft-annealed region is at least 18%, preferably at least 20%.
  • the elongation at break in a region subjected to aging is at most 3.5%.
  • the yield strength in region subjected to aging is at least 360 MPa, preferably at least 380 MPa.
  • the yield strength in a soft-annealed region is at least 240 MPa.
  • the tensile strength in a soft-annealed region is at least 390 MPa.
  • the diameter of the wire implant is 0.2 mm to 6.0 mm, preferably 0.5 mm to 4.0 mm, and the length of the wire implant is 30 mm to 600 mm, preferably 50 mm to 500 mm.
  • the final diameter, shape and form of the degradable wire implants are preferably produced from rod-shaped, semi-finished products by cold or hot working, i.e. by the well-known methods of rolling, extrusion and wire drawing. This list is not exhaustive. Other methods are also conceivable for a person skilled in the art.
  • the wire is round or polygonal or has longitudinal grooves. Also, threadlike depressions are possible. Instead of round wires, it is also possible to produce polygonal wires, for example triangular or square, or fluted wires having longitudinal grooves. These can be produced by extrusion or drawing using suitable matrices. It is also conceivable for the shape of the wire to be changed after its production by means of suitable methods, for example by means of milling.
  • the ends of the degradable wire implant can be flat or pointed. It is advantageous for the degradable wire implant, in particular a K-wire, to have a tip at at least one of the ends.
  • the tip can be designed for example as a trocar, lancet, chisel tip or as a drill neck.
  • the common trocar or lance-shaped tips can be added by milling, grinding, cutting or moulding.
  • a loop-shaped hole is present at least at one of the ends of the degradable wire implant, in particular a K-wire.
  • the wire implant has a smooth surface in at least one subsection, preferably a smoothly polished surface.
  • the wire implant has a roughness depth of less than 1.0 ⁇ m, preferably of 0.8 ⁇ m, in at least one subsection.
  • the roughness is measured as a Rz value (mean roughness depth).
  • the roughness depth can be achieved, for example, by mechanical polishing, by oscillating cross-grinding, so-called superfinishing. Also, special methods of electrochemical polishing can achieve this low degree of roughness. The low degree of roughness achieves extended degradation time or a reduced degradation rate.
  • the wire implant is hollow in at least one subsection.
  • One or more substances, preferably medications, can preferably be embedded in the cavity so that there is the possibility of postoperative pharmaceutical treatment of the patient.
  • this integrated drug depot becomes accessible over time, and delivery of the drug to the surrounding endogenous bone and soft tissue becomes possible. It is also possible to use a substance in the cavity which by its release can determine the degradation rate.
  • the aim is further achieved by a method for producing a wire implant, wherein the wire implant is subjected to a heat treatment over the entire length of the wire or in at least a subsection of the wire implant, and wherein the wire implant consists of a biocompatible, biocorrodible magnesium alloy composed of metallic magnesium of at least 80 wt. %, a zinc proportion of 0.1 to 2.0 wt. %, a zirconium proportion of 0.1 to 2.0 wt. %, a proportion of rare earth metals of 0.1 to 10 wt. %, wherein the yttrium content among the rare earth metal content proportion is 0.1 to 5.0 wt. %, a manganese proportion of 0.01 to 0.2 wt.
  • a magnesium alloy is first produced, which is advantageously composed of metallic magnesium of at least 80 wt. %, a zinc proportion of 0.1 to 2.0 wt. %, a zirconium proportion of 0.1 to 2.0 wt. %, a proportion of rare earth metals of 0.1 to 10 wt. %, wherein the yttrium content among the rare earth metal content proportion is 0.1 to 5.0 wt. %, a manganese proportion of 0.01 to 0.2 wt. %, an aluminium proportion of less than 0.1 wt. %, a copper, nickel and iron proportion in each case of less than 0.1 wt. %, and a proportion of other physiologically undesirable impurities totaling less than 0.8 wt. %, wherein the remainder of the alloy is magnesium up to 100 wt. %.
  • a magnesium moulding is preferably made.
  • a moulded part produced in this way is then further processed to the desired wire implant.
  • the final diameter, form and shape of the wire implants are preferably produced from semi-finished products by cold or hot working, in particular by the well-known methods of rolling, extrusion and wire drawing. This list is not exhaustive. Other methods are also conceivable for a person skilled in the art.
  • the heat treatment of the wire implant takes place over the entire length of the wire or in at least one subsection.
  • heat treatment is understood to mean treatment of the wire implant in one or more steps, wherein the wire implant is heated and cooled again in a certain time pattern in order to change material properties.
  • the wires are given sufficient torsional strength and bending strength for long, thin and knitting needle-shaped components.
  • the wire implant is subjected to heat treatment by solution annealing, quenching and subsequent artificial aging. Likewise, soft annealing is possible. This list is not exhaustive. Other methods of heat treatment are also possible for a person skilled in the art.
  • Solution annealing is preferably carried out at a temperature of from 300° C. to 550° C., preferably from 350° C. to 500° C., more preferably at 480° C.
  • the solution annealing is preferably carried out over a period of 2 to 100 minutes, particularly preferably 3 to 60 minutes.
  • the quenching is preferably carried out in water, oil or cold air.
  • Artificial aging is preferably carried out at 120 to 250° C., particularly preferably at 180° C. over a period of 2 h-48 h.
  • the solution annealing is carried out in a contactless manner by laser light or by inductive heating or by heating by means of infrared irradiation or in an oven, for example a muffle furnace or a tube furnace, preferably under protective gas or in a (partial) vacuum.
  • the wire implant is subjected to soft annealing as a form of heat treatment.
  • the soft annealing is carried out at 350° C. to 420° C., particularly preferably at 400° C., over a period of 5 to 60 minutes. If the entire wire implant is soft-annealed, the strength decreases, but the wire becomes deformable. If only a section of the wire implant is to become soft, the region that is to remain tough and stiff, such as the trocar tip, must be cooled during the procedure, or it must not be in the heat treatment zone of influence.
  • the values of the yield strength or tensile strength can be significantly lowered and the elongation at break increased.
  • the wires or wire sections treated by heat treatments are thus malleable and bendable.
  • particularly strong regions in terms of torsion and bending can also be produced by the heat treatment.
  • Aging achieves in particular high strengths, which in particular improve the tensile and torsional strength of the wire at the sites treated in this way.
  • the heat treatments can be used to make the degradation behaviour of the wire different in individual sections. Using heat treatment, degradation rates of 0.05 to 2.0 mm per year are possible in a heat-treated region.
  • the wire implant is heat-treated over its entire length.
  • the heat treatment takes place in at least one subsection.
  • heat treatment in about the middle third is advantageous, preferably in one third to two thirds of the total length of the wire implant.
  • the different possibilities of heat treatment such as aging and soft annealing can also be applied to a wire.
  • a wire having a high-strength tip can be produced, while the remainder of the wire is softer and more flexible.
  • the wire implant has a smooth surface, preferably a smoothly polished surface, in at least one subsection. It has been found that very smoothly polished surfaces of the degradable wire implants result in the almost always desired delay in the onset of degradation.
  • the low roughness depth can extend over the entire length of the wire or in at least one subsection. It has been found that a roughness depth of less than 1.0 ⁇ m leads to a delay in degradation of 100 to 200 hours.
  • the wire implant has a roughness depth of less than 1.0 ⁇ m, preferably of 0.8 ⁇ m, in at least one subsection.
  • the roughness is measured as the Rz value (average roughness depth).
  • the roughness depth can be achieved, for example, by mechanical polishing, by oscillating cross-grinding, so-called superfinishing. This low degree of roughness can also be achieved by special methods of electrochemical polishing or lapping. Low roughness achieves an extended degradation time or a reduced degradation rate.
  • Another subject matter of the present invention relates to a wire implant which is obtainable by the method described above.
  • FIG. 1 shows a biodegradable wire implant
  • FIG. 2 shows a biodegradable wire implant having a heat-treated section and a trocar tip.
  • FIG. 3 shows a biodegradable wire implant having polished sections.
  • FIG. 4 shows a biodegradable wire implant having a hexagonal outer profile.
  • FIG. 5 shows a biodegradable wire implant having a fluted profile.
  • FIG. 1 shows a schematic representation of the degradable wire implant (1).
  • a magnesium alloy comprising the following components is preferably first produced:
  • Nickel 0.003 wt. %
  • Aluminium 0.0032 wt. %
  • Lithium 0.0035 wt. %
  • a fabricated magnesium moulded part is further processed into the desired wire implant.
  • Aging achieves in particular high strengths, which in particular improve the tensile and torsional strength of the wire at the sites treated in this way.
  • the different possibilities of heat treatment such as aging and soft annealing can also be applied to a wire.
  • a wire having a high-strength tip can be produced, while the remainder of the wire is softer and more flexible.
  • FIG. 2 shows a biodegradable wire implant (2), which was heat-treated in the middle third (3) by soft annealing.
  • a wire of 1.0-mm diameter (D) was first produced by cold wire drawing, and then cut to a 200-mm length (L).
  • the yield strength in this heat-treated section is 264 MPa, and 394 MPa in the two non-heat-treated sections in the front third and back third (4).
  • the heat treatment in this subsection of the implant makes it possible to maintain unchanged hardness and toughness of the biodegradable K-wire in the region of the trocar tip (5), and keep it malleable and bendable in the middle region, and hard and tough in the rear region, the guide region.
  • the degradable wire implant can be continuously or sectionally varied in its corrosion rate and adapted to the medical case by polishing or by oxidising and polishing the surface.
  • FIG. 3 shows such a wire (6). This was heat-treated in the middle third by aging, and additionally polished over the front two thirds (7) of the length by means of oscillating grinding to provide a roughness (Rz, average roughness depth) of ⁇ 1 ⁇ m.
  • FIG. 4 shows a biodegradable wire implant having a hexagonal outer profile
  • FIG. 5 shows a biodegradable wire implant having a fluted profile.

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US16/540,910 2018-08-17 2019-08-14 Biodegradable Wire Implant Abandoned US20200054794A1 (en)

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DE102022109070A1 (de) 2022-04-13 2023-10-19 Soluterials Verwaltungs und Verwertungs UG (haftungsbeschränkt) Leichtmetall-Matrixverbundwerkstoff auf Magnesiumbasis und Verfahren zu seiner Herstellung
CN116172680B (zh) * 2023-04-26 2023-12-15 泓欣科创(北京)科技有限公司 防退克氏钉及克氏钉装置

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